U.S. patent application number 14/993926 was filed with the patent office on 2016-07-21 for effects of alpha-glycerophosphocholine versus caffeine in measures of cognitive, psychological and physiological functions.
The applicant listed for this patent is Chemi Nutra. Invention is credited to Lorenzo De Ferra, Chase Hagerman, Scott L. Hagerman, Ralf Jaeger, Martin Purpura, Maurizio Zenoni.
Application Number | 20160206637 14/993926 |
Document ID | / |
Family ID | 56406986 |
Filed Date | 2016-07-21 |
United States Patent
Application |
20160206637 |
Kind Code |
A1 |
De Ferra; Lorenzo ; et
al. |
July 21, 2016 |
Effects of Alpha-Glycerophosphocholine Versus Caffeine in Measures
of Cognitive, Psychological and Physiological Functions
Abstract
Alpha-glycerophosphocholine can replace and/or displace caffeine
wherever caffeine is used for its physiological benefits in dietary
supplements, in beverages, including energy drinks and shots, and
in foods and medical foods.
Inventors: |
De Ferra; Lorenzo; (Patrica,
IT) ; Hagerman; Scott L.; (Austin, TX) ;
Purpura; Martin; (Austin, TX) ; Jaeger; Ralf;
(Austin, TX) ; Hagerman; Chase; (Austin, TX)
; Zenoni; Maurizio; (Patrica, IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Chemi Nutra |
Austin |
TX |
US |
|
|
Family ID: |
56406986 |
Appl. No.: |
14/993926 |
Filed: |
January 12, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62102217 |
Jan 12, 2015 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23V 2002/00 20130101;
A23L 33/10 20160801; A23V 2250/304 20130101; A23L 33/30 20160801;
A23V 2200/33 20130101; A61K 31/685 20130101; A23V 2002/00
20130101 |
International
Class: |
A61K 31/685 20060101
A61K031/685; A61K 9/00 20060101 A61K009/00 |
Claims
1. A method of replacing physiological effects of caffeine
contained in dietary supplements, beverages and foods in a subject,
said method comprising: orally administering to said subject
dietary supplements, beverages and foods in which an effective
amount of .alpha.-glycerophosphocholine (.alpha.-GPC) substitutes
said caffeine; and obtaining said physiological effects in said
subject.
2. The method of claim 1, wherein said effective amount comprises
between about 20 mg to about 600 mg of .alpha.-GPC.
3. The method of claim 2, wherein said effective amount displaces
from about 50 mg to about 300 mg of caffeine.
4. The method of claim 1, wherein said effective amount of
.alpha.-GPC displaces or augments said physiological effects of
caffeine in said subject.
5. The method of claim 1, wherein said .alpha.-GPC provides for
cognitive and/or physical benefits similar to caffeine without
caffeine's detrimental physical and mental effects.
6. The method of claim 5, wherein said detrimental physical and
mental effects comprise anxiety, depression, jittery and crash.
7. A method of improving explosive power output in relation to
physical exercise in a subject, said method comprising: orally
administering to said subject dietary supplements, beverages and
foods in which an effective amount of .alpha.-GPC substitutes
caffeine; and improving said explosive power output in relation to
physical exercise in said subject.
8. The method of claim 7, wherein said effective amount comprises
between about 20 mg to about 600 mg of .alpha.-GPC.
9. The method of claim 7, wherein said effective amount substitutes
from about 50 mg to about 300 mg of said caffeine.
10-12. (canceled)
13. A method of improving cognitive abilities selected from the
group consisting of learning ability, recall, focus ability and
name and number recognition in a subject, said method comprising:
orally administering to said subject dietary supplements, beverages
and foods in which an effective amount of .alpha.-.alpha.-GPC
substitutes caffeine; and improving said cognitive abilities in
said subject.
14. The method of claim 13, wherein said effective amount comprises
between about 20 mg to about 600 mg of .alpha.-GPC.
15. The method of claim 13, wherein said effective amount
substitutes from about 50 mg to about 300 mg of caffeine.
16-36. (canceled)
Description
[0001] This U.S. Non-Provisional application claim priority to and
the benefit from U.S. Provisional Application 62/102,217 filed on
Jan. 12, 2015 incorporated herein by reference it its entirety.
BACKGROUND OF THE INVENTION
[0002] .alpha.-Glycerophosphocholine (.alpha.-GPC) is a nutritional
supplement that is converted to phosphorylcholine after
ingestion.
[0003] Once converted to phosphorylcholine, it has the ability to
provide a source of choline for synthesis and release of
acetylcholine (ACh), which is the predominant neurotransmitter in
the parasympathetic nervous system. ACh is responsible for
initiating all skeletal muscle contractions and is involved as a
neurotransmitter in various areas of the central nervous system
(Brownawell et al, 2011). Due to the effects .alpha.-GPC has on ACh
synthesis and release, .alpha.-GPC may positively affect cognitive
function and physiological performance (Hoffman et al., 2010;
Shields et al., 2014, Ziegenfuss et al., 2008).
[0004] After oral administration, .alpha.-GPC is converted to
phosphorylcholine, which is a metabolically active form of choline.
Phosphorylcholine migrates to the synaptic nerve endings found
throughout the entire central nervous system, and in turn increases
Ach synthesis and release. Ach is a vastly important
neurotransmitter present in both brain and muscle tissue. In the
brain ACh plays a key role in basically every cognitive function,
while in muscle, it is vitally involved in muscle contraction, as
it is the major neuro-transmitter involved in regulating
physiological response to exercise.
[0005] Starting in the spinal cord, motor neurons branch along
their axons and come in contact with muscle fibers at their motor
units, where ACh is called upon to deliver the action potential to
each muscle fiber at the motor end plate, thus initiating muscle
contraction. Motor units are recruited in order of their size (Size
Principle), starting with the smallest in size and weakest in
degree of tension they can generate. According to this principle,
the recruitment sequence begins with Type I motor units (slow
twitch, fatigue-resistant, highly oxidative), progresses to Type
IIa motor units (fast twitch, fatigue-resistant, oxidative and
glycolytic), and finally to Type IIb motor units (fast twitch,
fatigable, glycolytic).
[0006] It has been demonstrated through scientific study, that
engaging in intense exercise can cause a significant reduction in
plasma choline levels, thus reducing global stores of ACh, and
causing a negative impact on endurance and muscular performance.
From a physiological standpoint, this is best explained by the fact
that the diminishment of ACh substantially compromises the
continual firing of motor units and contraction of "movement
specific" muscle groups.
[0007] Further, as it can be hypothesized that since all muscle
movements--explosive power output, agility, jumping ability--are
related to contraction, and contraction is related to available ACh
stores, then maximizing ACh should optimize every type of muscular
performance.
[0008] Caffeine is a mild stimulant that may be found in the
leaves, fruits, and/or seeds of many plants such as, for example,
Thea species, Camellia species, Theobroma cacao, Coffee arabica,
and Cola species. The most common sources of caffeine include
coffee (e.g., seeds of Coffee arabica), tea (e.g., leaves of Thea
sinensis, Camellia sinensis, etc.), cola soft drinks (e.g.,
extracts of the nuts of Cola acuminata, Cola nitida, etc.),
chocolate (e.g., the seeds of Theobroma cacao), and
over-the-counter medications.
[0009] Caffeine is recognized as having many physiological and/or
pharmacological effects: it may, for example, stimulate the central
nervous system, promote analgesia, temporarily increase metabolic
function, relax smooth muscle, act as a diuretic, improve running
performance, aiding in recovery, providing cognitive support and
focus and improving weight lifting abilities, such as increasing
power output and strength
[0010] Tarnopolsky et al. Medicine and Science in Sports and
Exercise, 1989, 21(4): 418-424. Graham, T E. (1998) Effects of
Caffeine on Metabolism, Exercise Endurance and Catecholamine
Responses and Withdrawl. London. Spriet et al. Caffeine and
performance. Int J Sport Nutr. 1995. June:5 Suppl:S84-99. Anderson
et al. Improved 2000-meter rowing performance in competitive
oarsmen after caffeine ingestion. International Journal of Sport
Nutrition and Exercise Metabolism, 2000, 10(4):464-475.
[0011] Doherty et al. The effects of caffeine on the maximal
accumulated oxygen deficit and short-term running performance. Int
J Sport Nutr. 1998; 8:95-104. Armstrong, L. E. Caffeine, body
fluid-electrolyte balance, and exercise performance. Int J Sport
Nutr Exerc Metab. 2002; June; 12(2):189-206. Hodgson et al. The
Metabolic and Performance Effects of Caffeine Compared to Coffee
during Endurance Exercise. PloS One, 2013; 8(4): e59561 (published
online). Hogervorst et al. Caffeine improves physical and cognitive
performance during exhaustive exercise. Medicine and Science in
Sports and Exercise, 40 (10), 1841-1851.
[0012] The ability of caffeine to stimulate the central nervous
system and its ergogenic effects in short term and long endurance
are some of the reasons for the popularity of caffeine-containing
beverages, dietary supplements and foods. (e.g., caffeinated soft
drinks like Red Bull.RTM., Monster Energy.RTM., shots like 5-hour
Energy.RTM., and weight loss dietary supplements like Hydroxycut
Hardcore.RTM.)
[0013] There are many reasons that people turn to caffeinated
beverages and/or caffeine-containing stimulants products as to
promote alertness and physical endurance. Recuperation from certain
illnesses may leave one drowsy. Many jobs require a high level of
alertness and/or overnight working hours in which drowsiness on the
job may be dangerous to the worker and/or others (e.g., police
officer, security guard, over-the-road truck driver, etc.). The
demands of a school- or job-related deadline may force one to
remain alert working or studying into the night. The use of
caffeine to increase alertness typically involves ingesting a
"dose" of caffeine so that it is absorbed into the bloodstream
through the lining of the digestive tract.
[0014] A six-ounce cup of coffee can contain from about 40
milligrams (mg) to more than 150 mg of caffeine. A generally
accepted "average" caffeine content for a cup of coffee is 100 mg,
although many coffee-based drinks typically contain many times that
amount. For example, espresso may contain 100 mg of caffeine per
fluid ounce. Also, many popular coffee drinks are sold in sizes
much larger than the generally accepted "average" six fluid ounce
serving.
[0015] Certain soft drinks and energy drinks can contain from about
35 mg to about 80 mg of caffeine per serving and, like the
coffee-based beverages just described, are often sold in sizes
larger than a single serving. Chocolate can contain up to about 15
mg of caffeine per ounce. Certain over-the-counter stimulants
contain 100 mg to 200 mg of caffeine.
[0016] Despite their popularity, ingestible forms of caffeine such
as certain foods, caffeinated beverages, and ingestible
over-the-counter medications may not be suitable for all instances
in which one might desire to use caffeine to stay alert. For
example, caffeinated beverages and over-the-counter medications can
require the co-ingestion of fluids, sometimes in large volume. When
combined with the diuretic effect of caffeine, this can result in
diuresis or an undesirable frequency of urination, particularly if
one desires to remain alert in either an environment in which
adequate facilities are unavailable or circumstances in which
urination would be inconvenient.
[0017] Moreover, caffeine has fallen under scrutiny, especially
when consumed in dietary supplements, beverages (e.g. energy
drinks) and foods by children, adolescents and sensitive adults.
Specifically, individuals are concerns about caffeine and its
addictive qualities, long-term complete metabolic elimination, and
detrimental physical and mental effects including trembling, heart
rate increase, insomnia, chronic muscle tension, anxiety, and
irritability, and even toxicity.
[0018] In addition to these effects, numerous studies have
documented caffeine's ergogenic effect on athletic performance,
particularly in regard to endurance. Tarnopolsky. Caffeine and
endurance. Sports Med. 1994 August; 18(2):109-25. Pasman et al. The
effect of different dosages of caffeine on endurance performance
time. Int J Sports Med. 1995 May; 16(4):225-30.
[0019] Studies have shown that caffeine ingestion prior to
exercising extended endurance in moderately strenuous aerobic
activity. Goldstein et al. International society of sports
nutrition position stand: caffeine and performance. Journal of the
International Society of Sports Nutrition 2010, 7:5.
[0020] Other studies researching caffeine consumption on elite
distance runners and distance swimmers show increased performance
times following caffeine consumption. MacIntosh et al. Caffeine
Ingestion and Performance of a 1,500-Metre Swim. Canadian Journal
of Applied Physiology, 1995, 20(2): 168-177. Stephen et al.
Caffeine and Exercise Performance. Sports Medicine January 1993,
Volume 15, Issue 1, pp 14-23.
[0021] It has now been found that .alpha.-GPC, acting as a potent
donor of choline, and the subsequent biosynthesis of acetylcholine
(ACh), the body's primary neurotransmitter, acts similarly to
caffeine. Hoffman J R, et al. The effects of acute and prolonged
CRAM supplementation on reaction time and subjective measures of
focus and alertness in healthy college students. J Int Soc Sports
Nutr. (2010). Shields et al. The effects of a multi-ingredient
cognitive formula on alertness, focus, motivation, calmness and
psychomotor performance in comparison to caffeine and placebo.
Journal of the International Society of Sports Nutrition 2014,
11(Suppl 1):P45.
[0022] Therefore .alpha.-GPC can replace and/or displace caffeine
wherever caffeine is used for its physiological benefits in dietary
supplements, in beverages, including energy drinks and shots, and
in foods and medical foods.
SUMMARY OF THE INVENTION
[0023] The purpose of this investigation is to determine the acute
effects of .alpha.-GPC on cognitive, psychological, and
physiological functions compared to caffeine and a placebo.
BRIEF DESCRIPTION OF DRAWINGS
[0024] FIG. 1 shows the effects of .alpha.GPC-L, .alpha.GPC-H and
caffeine in comparison to placebo in the Serial Subtraction
Test.
[0025] FIG. 2 shows the effects of .alpha.GPC-L, .alpha.GPC-H and
caffeine in comparison to placebo on vertical jump peak power;
[0026] FIG. 3 shows the results on the VAS for jitteriness.
[0027] FIG. 4 shows the flowchart of the procedure described in
Experiment 2
[0028] FIG. 5 shows the change in isometric Mid-Thigh Pull Peak
force after 6 days of supplementation of .alpha.-GPC.
[0029] FIG. 6 shows the change in Upper-body Isometric Test force
after 6 days of supplementation of .alpha.-GPC.
DETAILED DESCRIPTION OF THE INVENTION
[0030] Accordingly, the presently claimed invention relates to
compositions and methods for the administrations of .alpha.-GPC in
energy drinks, shots, foods and medical foods replacing and/or
displacing caffeine wherever caffeine is used for it physiological
benefits.
[0031] In one embodiment, the invention provides for oral ingestion
of .alpha.-GPC to replace caffeine in dietary supplements,
beverages and foods.
[0032] In another embodiment, the invention also provides for oral
ingestion of .alpha.-GPC to displace, replace or augment caffeine
in dietary supplements, beverages and foods.
[0033] The invention provides for oral ingestion of .alpha.-GPC to
improve explosive power output in relation to physical
exercise.
[0034] The invention also provides for oral ingestion of
.alpha.-GPC to improve abilities in combative sports and similar
activities. A combative sports describes a contact sport with
one-one combat in an individual, for example boxing, kickboxing,
amateur wrestling, judo, Brazilian Jujitsu, mixed martial arts, and
Muay Thaias, as well as part of a team sport with contact, for
example American Football, Rugby, Ice hockey, Soccer.
[0035] The invention further provides for oral ingestion of
.alpha.-GPC to improve cognitive abilities, learning, recall, focus
and name and number recognition. Focus describes a person, mentally
and physically, having a state or condition permitting clear
perception or understanding. Better focus improves the person's
center of activity, attraction, or attention, conducting more than
one mental or physical task. Another definition describes focus as
having or giving the proper sharpness of outline.
[0036] The invention also relates to oral ingestion of .alpha.-GPC
to improve running and sprinting speed, to improve agility and
balance and to improve speed up recovery from repeated physical
exercise. Agility is the ability to change the body's position
efficiently, and requires the integration of isolated movement
skills using a combination of balance, coordination, speed,
reflexes, strength, and endurance. Agility is the ability to change
the direction of the body in an efficient and effective manner and
to achieve this requires a combination of balance--the ability to
maintain equilibrium when stationary or moving (i.e. not to fall
over) through the coordinated actions of our sensory functions
(eyes, ears and the proprioceptive organs in our joints); static
balance--the ability to retain the center of mass above the base of
support in a stationary position; dynamic balance--the ability to
maintain balance with body movement; speed--the ability to move all
or part of the body quickly; strength--the ability of a muscle or
muscle group to overcome a resistance; and lastly,
co-ordination--the ability to control the movement of the body in
co-operation with the body's sensory functions (e.g., in catching a
ball [ball, hand and eye co-ordination]). In sports, agility is
often defined in terms of an individual sport, due to it being an
integration of many components each used differently (specific to
all of sorts of different sports). Sheppard and Young (2006)
defined agility as a "rapid whole body movement with change of
velocity or direction in response to a stimulus". Agility is also
an important attribute in many role playing games, both computer
games and as Dungeons and Dragons. Agility may affect the
character's ability to evade an attack or navigate uneven
terrain.
[0037] The invention further relates to oral ingestion of
.alpha.-GPC for increasing workload and enhance training to improve
physical performance. Physical performance relates to the ability
to complete certain physical tasks with higher intensity, faster,
or with a higher power output. Improvement, maintenance or reduced
loss of physical performance may be a beneficial physiological
effect for individuals performing physical exercise for different
reasons (e.g. athletes preparing for a competition or during a
competition, and individuals engaged in physical work or
recreational activities), but also for individuals performing
common (non-exercise-related) physical tasks. Information on the
characteristics (e.g. type, duration and intensity) of the exercise
or physical activity for which the claim is made may be important
for the definition of the claimed effect (e.g. physical performance
during short-term, high intensity exercise vs. longer term,
endurance performance; single exercise bout vs. repeated bouts;
weight bearing vs. non-weight bearing activities) and of the target
population for the claim (e.g. athletes and elderly subjects).
Outcome measures of physical performance which may be appropriate
for the assessment of the claimed effect in humans in the context
of a particular type of exercise or physical activity should be
indicated (e.g. time spent to run a certain distance, distance
cycled during a time-trial, throwing distance in javelin or shot
put, jumping height, walking speed and number of chair-stands in a
certain time). Some of the outcomes proposed (e.g. changes in
maximum oxygen consumption (VO2max), muscle glycogen stores and
substrate oxidation) are not direct measures of performance but
could be used in support of a mechanism by which the
food/constituent could exert the claimed effect on physical
performance.
[0038] The invention further relates to oral ingestion of
.alpha.-GPC to improve reaction time in relation to daily
activities and in physical exercise.
[0039] The invention is directed to compositions and methods for
the administrations of .alpha.-GPC in energy drinks, shots, foods
and medical foods for replacing and/or displacing caffeine wherever
caffeine is used for it physiological benefits.
[0040] Formulations containing an oral dosage of between about 20
mg to about-600 mg of .alpha.-GPC can be used to affect mental and
physical performance. The formulations of .alpha.-GPC can be
included in dietary supplements, beverages and foods.
[0041] An oral dosage of between about 20 mg to about 600 mg of
.alpha.-GPC can be used to replace and/or displace from about 50 mg
to about 300 mg of caffeine.
[0042] This experimental protocol is given in detail in order to
more clearly explain how to make and use the invention and do not
limit the scope of the appended claims.
[0043] Approximately 20 recreationally active participants (10
males and 10 females) between the ages of 18 and 29 years of age
were recruited to participate in this study.
[0044] Participants were not allowed to take part in this research
if they meet any of the following criteria: 1) have current or past
history of anabolic steroid use; 2) have any metabolic disorders
including known electrolyte abnormalities; heart disease,
arrhythmias, diabetes, thyroid disease or hypogonadism; a history
of hypertension, hepatorenal, musculoskeletal, autoimmune, or
neurologic disease; if they are taking thyroid, hyperlipidemic,
hypoglycemic, anti-hypertensive, or androgenic medications; 3) have
ingested any ergogenic levels of creatine, HMB, thermogenics,
ribose, pro-hormones (i.e., DHEA, androstendione, etc.) or other
purported anabolic or ergogenic nutritional supplements for a
1-month time period prior to beginning the study and to not take
any additional nutritional supplement (except a vitamin/mineral
supplement) or contraindicated prescription medication during the
protocol. All participants meeting entrance criteria signed
informed consent statements in compliance with the Human
Participants Guidelines of Angelo State University.
[0045] Independent and Dependent Variables
[0046] The independent variables used throughout this study were
the nutritional supplementation and the number of
testing/evaluation times during the study. Dependent variables
included cognitive function, mood, reaction time, hand-eye
coordination, power, speed, and agility.
[0047] Entry and Familiarization Session
[0048] Participants expressing interest in participating in this
study were interviewed to determine whether they appeared to
qualify to participate in this study. Participants believed to meet
eligibility criteria were invited to attend an
entry/familiarization session. During this session, participants
signed Informed Consent Statements and complete medical histories.
Participants meeting entry criteria were familiarized to the study
protocol via a verbal and written explanation outlining the study
design. This included describing the supplementation protocol,
familiarizing the participants to the tests to be performed, and
practicing all testing procedures.
[0049] Testing Protocol
[0050] Participants arrived at the Human Performance Laboratory at
Angelo State University having fasted for at least 8 hours prior to
the testing protocol. Participants were also asked to refrain from
consuming any food or beverages that contain caffeine or other
stimulants for at least 24 hours prior to each testing session.
Following supplementation, participants performed all non-fatiguing
tests first. These tests included resting heart rate using a Polar
heart rate monitor (Polar Electro, Inc., Lake Success, N.Y.) and
blood pressure (aneroid sphygmomanometer), the serial subtraction
test to measure cognitive function, visual analog scales
(motivation, calmness, focus, fatigue, vigor, and jitteriness), the
online reaction time test
(www.humanbenchmark.com/tests/reactiontime/), and the hand-eye
coordination test. For the serial subtraction test, participants
were asked to repeatedly subtract the number 7 from a random
4-digit number for a period of 2 minutes. Participants were scored
by average time per correct calculation and percentage of correct
calculations. The visual analog test were administered by asking
the participants to indicate how they feel on a linear scale from
0-10 by making a vertical line on a 10 cm long horizontal line. The
distance from 0 was measured using a metric ruler.
[0051] The online reaction time test required the participants to
click a mouse button when the computer screen changes color from
red to green. The average reaction time over 5 attempts was
recorded. For the hand-eye coordination test, participants were
asked to bounce a tennis ball off of a wall from a distance of 2
meters. The participant were required to throw the ball with their
right hand, catch it in their left hand, throw the ball with their
left hand, and catch the ball with their right hand. This was
repeated for a total of 30 seconds.
[0052] Participants were scored by the total number of successful
catches. Following the non-fatiguing tests, the participants
performed a standardized warm-up in which they walked on a
treadmill for 5 minutes at 3 miles per hour. Following the warm-up,
participants performed the fatiguing tests which included vertical
jump, broad jump, 40 yard dash, and the pro-agility shuttle. During
the vertical jump test, participants performed three attempts and
had a Tendo Unit (Tendo Sport Machines, Trencin, Slovak Republic)
attached to their waist to measure maximum velocity and power
output in addition to measuring their vertical jump height using a
Vertec Jump Measurement System (Jump USA, Sunnyvale, Calif.).
Participants then performed three attempts for the standing broad
jump. Maximum broad jump distance was recorded. Lastly,
participants performed one 40 yard dash and one pro-agility shuttle
(5-10-5 drill) on an indoor, wooden gymnasium floor. Times was
measured by hand and recorded.
[0053] Supplementation Protocol
[0054] Upon arrival to the Human Performance Laboratory at Angelo
State University on each of the 4 testing sessions, participants
were provided with a sample of the supplement. Participants were
assigned to consume a placebo, 200 mg of caffeine, 200 mg of
.alpha.-GPC, and 400 mg of .alpha.-GPC in a randomized,
double-blind, placebo controlled, cross-over manner. After
consuming the supplement, participants waited 30 minutes before
completing the testing protocol. All participants were advised that
they should not have had anything to eat or drink, except for
water, in the previous 8 hours. Additionally, participants were
asked to refrain from consuming any food or beverages that contain
caffeine or other stimulants for at least 24 hours prior to
completing the testing sessions.
TABLE-US-00001 FAM Session Supplement 1 Supplement 2 Supplement 3
Supplement 4 Familiarization Consume Randomly Consume Randomly
Consume Randomly Consume Randomly session, Assigned Assigned
Assigned Assigned complete supplement supplement supplement
supplement paperwork. Review medical history Complete all Perform
non- Perform non- Perform non- Perform non- familiarization
fatiguing tests (SST, fatiguing tests (SST, fatiguing tests (SST,
fatiguing tests (SST, practice tests VAS, reaction time, VAS,
reaction time, VAS, reaction time, VAS, reaction time, for all
hand-eye hand-eye hand-eye hand-eye dependent coordination)
coordination) coordination) coordination) variables Perform Perform
Perform Perform standardized warmup standardized warmup
standardized warmup standardized warmup Perform all other Perform
all other Perform all other Perform all other tests (vertical jump,
tests (vertical jump, tests (vertical jump, tests (vertical jump,
broad jump, 40 yard broad jump, 40 yard broad jump, 40 yard broad
jump, 40 yard dash, pro-agility dash, pro-agility dash, pro-agility
dash, pro-agility shuttle) shuttle) shuttle) shuttle)
Example 1
Methods
[0055] Twenty participants (10 males, 10 females; 22.0.+-.3.4 years
of age; height 171.9.+-.7.4 cm; weight 56.8.+-.8.6 kg) consumed 200
mg of .alpha.GPC (.alpha.GPC-L, Alpha-Size.RTM., Chemi Nutra,
Austin, Tex. USA), 400 mg of Alpha-GPC (.alpha.GPC-H), 200 mg of
caffeine (CA), and a placebo (PL) in a randomized, double-blind,
placebo-controlled, crossover design. Participants performed the
following measurements 30 minutes after supplementation: visual
analog scales (VAS) for six different moods, a serial subtraction
test (SST), and tests for reaction time, hand-eye coordination,
power, speed and agility.
Results
[0056] SST scores were 18.1% and 10.5% faster in the .alpha.GPC-L
(6.19.+-.2.21 s) group compared to CA (7.32.+-.5.67 s) and PL
(6.85.+-.2.52 s), respectively (FIG. 1). Vertical Jump Peak Power
was 8.5% higher in the .alpha.GPC-L (2,041.3.+-.547.2 W), 7.5%
higher in the .alpha.GPC-H (2,023.1.+-.942.8 W) and 2.0% higher in
the CA group (1,920.4.+-.689.6 W) in comparison to PL
(1,881.9.+-.689.6 W) (FIG. 2).
[0057] The group consuming CA had significantly higher scores on
the VAS for jitteriness compared to .alpha.GPC-H, but not
.alpha.GPC-L or PL (FIG. 3).
Conclusion
[0058] .alpha.-GPC seemed to be beneficial for certain physical and
mental performance tasks and is at least as effective as CA,
without displaying the negative side effects of CA
supplementation
Example 2
[0059] Ergogenic aides are widely used by fitness enthusiasts and
athletes to increase performance. .alpha.-GPC has demonstrated some
initial promise in changing explosive performance. The purpose of
the present investigation was to determine if 6 days of
supplementation with .alpha.-GPC would augment isometric force
production compared to a placebo.
Methods
[0060] The Institutional Review Board at the University of
Louisiana at Lafayette reviewed the present investigation for
ethics. The study was a double-blind, placebo-controlled crossover
with a 1-week washout period that included 13 healthy, college-aged
males (Means.+-.SD; Age: 21.9.+-.2.2 years, Height: 180.3.+-.7.7
cm; Weight: 87.6.+-.15.6 kg, VO.sub.2 max: 40.08.+-.7.23 ml
O.sub.2*kg.sup.-1; body fat: 17.5.+-.4.6%). Subjects reported to
the lab and give informed consent, which included consent to
publish, prior to baseline assessments, which included height and
weight, an assessment of maximum aerobic capacity via a COSMED CPET
system (COSMED, Rome ITL) with integrated electronically braked
cycle ergometer as outlined in previous studies incorporated herein
by reference (5) and body fat percentage via air displacement
plethysmography (Bod Pod Gold Standard System, COSMED Rome, ITL).
The following week trial one (random order: either placebo or 600
mg of .alpha.GPC) began. For the trials baseline performance
testing was done and they were given an initial dose (placebo or
.alpha.-GPC) while in the lab, 1 h later the performance testing
(isometric mid-thigh pull, upper body isometric test) was repeated.
The subjects were then given 6 days of additional pre-packaged
supplement to take (morning and evening). The subjects reported
back on day 6 of this period to repeat performance testing after
the final dose of supplement. After a 1-week washout period, the
subjects repeated the trial with the other treatment (see FIG.
4).
Treatments
[0061] The treatments consisted of 600 mg daily of .alpha.-GPC
(Alphasize.RTM., ChemiNutra, Austin Tex.) or a placebo. Both
treatments were administered in the same capsules (gel caps) and
were the same color (white). The .alpha.-GPC capsules were supplied
with a certificate of analysis from a third party lab confirming
the amount of active ingredient. The placebo capsule consisted of
microcrystalline cellulose and magnesium stearate (Nature's
Supplements, Carlsbad, Calif. USA). Both the participant and
researcher were unaware of the identity of either treatment until
the end of the study. The participants were instructed to take
doses in the morning and evening that would deliver a total of 600
mg of .alpha.-GPC per day and were given the pills in a
non-distinct plastic bottle marked only with a code. The
participants returned the bottles at the end of the study.
[0062] The participants reported 100% compliance with taking the
required doses.
Isometric Mid-Thigh Pull (IMTP)
[0063] The isometric mid-thigh pull test (IMTP) is a well validated
strength measure (Beckman, G, et al. "Relationship of isometric
mid-thigh pull variables to weightlifting performance." J. Sports
Med. Phys Fitness 2010; 35:573-81). Testing was conducted in a
customized power rack (Rogue Fitness, Columbus, USA) that is
secured to a concrete laboratory floor surrounding a AMT1 Force
Plate (Advanced Materials Technologies Inc., Watertown USA). The
power rack allows for small incremental adjustments in height for a
steel bar that is secured via two large tubular steel members. The
participant was instructed to stand with the feet shoulder width
apart above the force plate. The height of the bar was adjusted so
that the participant was in a position where the torso was upright
(assessed via a contractors box level), the knees achieved between
120-130.degree. of flexion (measured via a goniometer) and the arms
were straight while holding the bar. The participants were told to
"drive straight up" and to pull as hard as they could against the
chain until the force began to noticeably decline. The peak force
was assessed at a sampling rate of 2000 Hz using an AMT1 Force
Plate. Subjects were familiarized with the IMTP during the initial
lab visit. Measurements were taken in triplicate with a five-minute
rest.
Upper Body Isometric Test (UBIST)
[0064] The participants were positioned on three elevated platforms
with the chest directly suspended over a load cell anchored into
the concrete floor of the lab (iLoad Pro, Loadstar Sensors, Fremont
Calif.). The load cell had a capacity of greater than 5000 r and a
listed accuracy of 0.25% for the full scale of measurement. The
participants were placed in a push-up style position, with the
hands at 150% of biacromial width, and the elbows at 90.degree. of
extension (measured via a goniometer). A thick, non-elastic strap
was run over one shoulder and under the opposite shoulder and
connected with metal rings to a chain that was tethered to the load
cell. The participants were instructed to keep their backs flat,
and push with their hands maximally until told to stop by the
researcher. Prior to data capture the load cell was tared to ensure
the weight of the load cell and apparatus were accounted for. The
researcher started data collection and verbally instructed the
participant to "push as hard as possible". The participants were
verbally encouraged during data collection, which was terminated
when the force production declined by 50 N from the peak value
registered. The load cell was set to capture data at maximum rate
(150 Hz) and the data was exported and analyzed in JMP 11.0 (SAS
Institute Inc, Ca1y NC). Peak force values were isolated from the
data and used for subsequent analysis. The test was performed three
times with 5 min rest between assessments. The validity and
reliability of this test have been reported in the literature.
Statistical Analysis
[0065] Reliability was assessed for the isometric tests via Intra
Class Correlation Coefficients (ICC). Repeated measures Anovas were
used to examine acute (baseline and 1 h post) and chronic (baseline
and day 6) changes in performance between treatments. Order of
administration (Placebo first, A-GPC first) was entered into the
model as a covariate. G* Power software was used to determine
effect size (Cohen's d), all other analyses were performed using a
modern statistical software package (JMP, version 11.0 SAS
Institute Inc., Caty, N.C.). Magnitude based inferences were
calculated to assist with interpretation of results. The use of
magnitude based inference is an attempt to expand the
interpretation of findings to include harmful, trivial and
beneficial as interpretations, rather than just significant,
nonsignificant. This interpretations in not without controversy as
such the authors have chosen to include it along-side a more
traditional statistical approach.
Results
Reliability of Isometric Tests
[0066] The isometric tests demonstrated reliability when the
triplicate measurements were examined via ICC (range: 0.969-0.984).
Measurements were not different at any time points (p>0.05).
Therefore in subsequent analysis the peak value from the set of
three measures was used.
Treatment Effects-Acute
[0067] Repeated measures Anova did not reveal any main effects
(F=0.003, p=0.9584) nor interaction effects of treatment time
(F=0.114, p=0.738) for IMTP performance 1 h after the initial close
of A-GPC or Placebo. Similar results were revealed with UBIST
performance was analyzed.
Treatment Effects-Chronic
[0068] Repeated measures Anova revealed a significant interaction
effect for treatment (A-GPC vs Placebo) by time (baseline, day 6)
for lMTP peak performance (F=3.12, p=0.04; change from baseline
A-GPC: 98.8..+-.236.9 N vs Placebo: -39.0.+-.170.9 N, ES=0.961).
See FIG. 5. For the upper body test the .alpha.-GPC treatment
trended towards greater change from baseline force production
(A-GPC: 50.9.+-.167.2 N Placebo: -14.9.+-.114.9 N) but the
interaction effect of treatment by time failed to obtain
statistical significance (F=1.36, p=0.127). However, this data (see
FIG. 6) demonstrated a large effect size (ES=0.714). This suggests
that the variability of the subject's upper body strength limited
the statistical power, however, it if likely that a real effect
exists in this data. Magnitude based inferences suggest that the
.alpha.-GPC was 68.3% likely beneficial for increasing upper body
isometric force and 86.5% likely beneficial for increasing lower
body isometric force production.
Discussion
[0069] The results of this study support the use of A-GPC to
enhance strength, particularly in the lower body. The literature
does not contain controlled experimental data regarding the effects
of A-GPC on aspects of human performance directly related to
strength, and thus this study represents a first step in the
evaluation of this product for such use. The literature does
contain some evidence that choline itself is important to consider
in regard to endurance performance. While further studies will be
needed to confirm the results reported from this experiment, the
data represent a promising start and suggest alternative uses for
A-GPC.
[0070] The potential mechanism by which A-GPC could confer enhanced
strength and power performance involves increased bio-available
choline, which may results in augmented acetylcholine synthesis in
neurons. A-GPC has been shown to augment acetylcholine levels in
CNS neurons. Several studies have shown that when administered
either intramuscularly or orally A-GPC can increase plasma choline
levels. A-GPC has also been shown to increase growth hormone
secretion though the action of acetylcholine stimulated
catecholamine release. This increase in cholinergic tone and
associated increased growth hormone release was also reported in
old and young subjects after administration of growth hormone
releasing hormone in conjunction with A-GPC.
[0071] While the present study presents positive preliminary
findings for A-GPC augmenting strength, it is not without
limitation. The study will need to be replicated with alternative
measures of human performance, likely those that have the capacity
to measure power not just peak force. Additionally, different does
of A-GPC need to be explored to determine any potential
dose-response, or lower limit for meaningful effect. We suggest
that in vitro studies may also be warranted to demonstrate that
A-GPC has the potential to augment neurotransmitter levels in motor
neurons.
CONCLUSIONS
[0072] The results of the study suggest that A-GPC is effective at
increasing lower body force production after 6 days of
supplementation. A similar trend was noted in upper body isometric
strength, however; this failed to attain statistical significance.
Given that in many sports it is understood that a very small change
in performance, often times less than 2 percent, can significantly
affect outcomes it is important to note that the 6 days of A-GPC
resulted in greater than a 3 percent increase in lower body
isometric strength. Sport performance coaches can consider adding
A-GPC to the diet of speed and power athletes to enhance muscle
performance.
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